Cognition Therapeutics Inc. said it is moving to the next stage of clinical testing with oral, small-molecule candidate CT-1812, despite phase II efficacy results falling short of statistical significance in patients with mild to moderate Alzheimer’s disease and sending shares of the Purchase, N.Y.-based company (NASDAQ:CGTX) falling 44%, or $1.04, to close July 29 at $1.33.
Ensho Therapeutics Inc. launched in July after licensing a pipeline of four oral α4β7 inhibitors for inflammatory and gastrointestinal disorders, including inflammatory bowel disease (IBD), from EA Pharma Co. Ltd. “Millions of people worldwide are living with IBD,” Ensho founder, president and executive chair Neena Bitritto-Garg recently told BioWorld, “and while there are a number of approved medications to address the symptoms of IBD, it remains a difficult-to-treat disease with high relapse rates for a considerable proportion of patients.”
Ipsen SA, of Paris, struck a $461 million deal with Day One Biopharmaceuticals Inc. for ex-U.S. rights to tovorafenib, an oral drug for pediatric brain tumor that gained U.S. FDA accelerated approval April 23 as Ojemda (tovorafenib).
The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. This is the third FDA-approved treatment for severe alopecia areata in the past three years.
Those affected by primary biliary cholangitis (PBC) are fighting back against the recommendation by the EMA that the marketing authorization for Ocaliva (obeticholic acid), a second-line treatment used by 7,000 patients in Europe, be withdrawn. Earlier today, July 25, patients and their supporters staged a protest outside the European Commission building in Brussels to oppose EMA’s position that Ocaliva’s conditional license should be revoked.
A phase II failure with SAGE-324 in essential tremor (ET) had Wall Street speculating about the fate of Sage Therapeutics Inc.’s partnership with Biogen Inc. Shares of Cambridge, Mass.-based Sage (NASDAQ:SAGE) ended July 24 at $10.38, down $2.70, or 20.6%, after the firm disclosed top-line results from the phase II Kinetic 2 dose-ranging study of oral SAGE-324 (also known as BIIB-124) for ET. The trial did not show a statistically significant dose-response relationship based on the primary endpoint, the Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 (upper limb) total score.
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, mazdutide, met the primary endpoint and all key secondary endpoints in a phase III type 2 diabetes trial in Chinese adults. “Mazdutide is the first and fastest-developed GLP-1R/GCGR dual agonist in the world, and we are actively promoting the development of mazdutide for weight loss, T2D and other indications,” Lei Qian, Innovent’s vice president of clinical development, said.
Aveo Pharmaceuticals Inc., a LG Chem Ltd. subsidiary, said that Fotivda (tivozanib) in combination with Bristol Myers Squibb Co.’s Opdivo (nivolumab) failed to increase progression-free survival (PFS) in advanced kidney cancer patients in a phase III Tinivo-2 study. Despite the primary endpoint miss, Aveo noted that Fotivda alone, or as a monotherapy, in the control arm meaningfully extended median PFS, helping “further support the approved use of Fotivda as a safe and effective treatment option in relapsed or refractory advanced [renal cell carcinoma] RCC following two or more prior systemic therapies.”
A schizophrenia drug in Cerevel Therapeutics Inc.’s lineup understandably stole much of the thunder during coverage of Abbvie Inc.’s takeover late last year to the tune of $8.7 billion, but much further back in the pipeline awaits another potentially lucrative prospect: a kappa opioid receptor antagonist (KORA) for major depressive disorder (MDD).
Aussie biotech Alterity Therapeutics Ltd. released interim data of an open-label phase II trial for lead candidate ATH-434 for treating multiple system atrophy that showed 43% of participants improved, with 29% showing either stable or improved neurological symptoms.
RSS
